Sr QA Engineer
Core
Senior Quality Engineer leading complex investigations, developing quality systems, and ensuring regulatory compliance for medical device manufacturing.
Role type
Senior IC Quality Engineer (Medical Devices)
Builds
Medical devices (Continuous Glucose Monitoring systems)
Domain
Healthcare / Medical Devices / Biosensing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, Validation, Risk management, Statistical tools, CAPA development, Regulatory compliance (FDA QSR, ISO 13485), Six Sigma
Preferred skills
Leadership, Cross-functional collaboration, Coaching, Problem-solving
Technologies
FDA QSR, ISO 13485, Six Sigma
Responsibilities
Lead complex investigations and CAPA development, Implement and maintain quality assurance protocols, Ensure compliance to internal and external standards, Drive long-term corrective and preventive actions, Mentor engineers and shape best practices, Assist in high-visibility quality engineering projects
Seniority
Senior, hands-on IC with strategic influence
